MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Model Number	82-6631
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The microsensor was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.
Event or Problem Description
A facility reported that prior to placement of the microsensor from the neuromonitor basic kit the microsensor was not able to be detected by the icp monitor.The physician changed out the microsensor which was then detected normally.There was no delay reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Unique device identification (udi): (b)(4).The neuromonitor basic kit was returned for evaluation: device history record (dhr) - there is no indication that the production process may have contributed to this complaint.Failure analysis - slight film over the sensor area and minor kinks along catheter body.The device passed electronic, noise, linearity/hysteresis, and signal drifts tests.The issue of the complaint was not confirmed.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to probe connector housing is impacted by external force.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10221156
• Report Number: 1226348-2020-00362
• Device Sequence Number: 19401232
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: (01)20886704042317
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 3640901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 06/14/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1